Stapler cartridge with staples frangibly affixed thereto

ABSTRACT

A surgical apparatus may include a cartridge, and surgical staples affixed to and frangibly separable from that cartridge. A method for surgical stapling utilizing that apparatus may include providing at least one wedge; and moving at least one wedge into the cartridge, where that moving deforms and then shears from the cartridge at least one staple. A method of manufacturing an apparatus for use with a surgical stapler may include fabricating a cartridge configured to be received by the surgical stapler; fabricating staples; and fixing the staples to the cartridge.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of copending application Ser.No. 12/683,382, filed Jan. 6, 2010, and priority is hereby claimed under35 U.S.C. §120.

FIELD OF THE INVENTION

The invention generally relates to surgical staplers and stapling.

BACKGROUND

An endocutter is a surgical tool that staples and cuts tissue totransect that tissue while leaving the cut ends hemostatic. Anendocutter is small enough in diameter for use in minimally invasivesurgery, where access to a surgical site is obtained through a trocar,port, or small incision in the body. A linear cutter is a larger versionof an endocutter, and is used to transect portions of thegastrointestinal tract. A typical endocutter receives at its distal enda disposable single-use cartridge with several rows of staples, andincludes an anvil opposed to the cartridge. The staples may be held inindividual pockets, with staple drivers underneath each staple. As awedge advances into the cartridge, that wedge sequentially pushes anumber of staple drivers upward, and the staple drivers in turn bothlinearly push each corresponding staple upward out of its pocket,deforming it against an anvil. The manufacturing process required toplace those small individual staples and staple drivers in thecorresponding small pockets is difficult, and the number of partsinvolved complicates the system and requires a minimum size of cartridgethat may be larger than optimally desired.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary cartridge and exemplarywedge assembly.

FIG. 2 is a top cutaway view of the exemplary cartridge of FIG. 1.

FIG. 3 is a perspective cutaway view of the exemplary cartridge of FIG.1.

FIG. 4 is a side cross-section view of the exemplary cartridge of FIG.1, with staples omitted for clarity.

The use of the same reference symbols in different figures indicatessimilar or identical items.

DETAILED DESCRIPTION

U.S. patent application Ser. No. 12/400,790, filed Mar. 9, 2009,entitled the “Feeder Belt Document,” is hereby incorporated herein byreference in its entirety. The Feeder Belt Document describes exemplaryfeeder belts used in a surgical stapler, to which a plurality of staplesare frangibly connected. Because new staples are fed to an end effectorof a surgical stapler by the feeder belts for sequential deployment, thesurgical stapler of the Feeder Belt Document does not need or utilize aplurality of single-use cartridges in order to deploy multiple sets ofstaples.

As is commonly used in the medical device industry, particularly in thesurgical stapler business, the term “cartridge” means, and is expresslydefined in this document to mean, a portion of a surgical stapler thatholds at least one staple, and that is insertable within and releasablyconnected to a remainder of the surgical stapler. Referring to FIG. 1,an exemplary cartridge 2 is shown, along with an exemplary wedgeassembly 4 and knife 6. The cartridge 2 may be utilized in conjunctionwith any surgical stapler that is capable of receiving it, and thatincludes at least a wedge assembly 4 capable of moving into thecartridge 2 to deploy staples (as described in greater detail below) andthen moving out of the cartridge 2 to allow the spent cartridge 2 to beremoved from the surgical stapler. The cartridge 2 may be received in aremainder of a surgical stapler in any suitable manner, such as by apressure fit or interference fit; passively or affirmatively; or in anyother suitable manner. The cartridge 2 may be received at the distal endof a remainder of the surgical stapler, and/or along the side of aremainder of the surgical stapler. The cartridge 2 may be useful inconjunction with an articulated surgical stapler having an articulationproximal to the location at which the cartridge is attached to thestapler. Such an articulation may be, for example, as described in U.S.patent application Ser. No. 12/400,760, filed Mar. 9, 2009, or in U.S.patent application Ser. No. 12/612,614, filed Nov. 4, 2009, both ofwhich are hereby incorporated herein by reference in their entireties.

The cartridge 2 may be shaped in any suitable manner. As one example,the cartridge 2 may include an upper surface 8. The upper surface 8 maybe generally flat, and generally rectangular. However, the upper surface8 need not be generally flat along all or part of its area, and may beshaped in a manner other than rectangular. Further, the upper surface 8need not be a discrete part of the cartridge 2, and instead simply maybe a portion of a larger surface or area of the cartridge 2. The uppersurface 8 of the cartridge 2 may include a plurality of openings 10defined completely therethrough. As described in greater detail below,each opening 10 may be aligned with a corresponding staple, such that astaple may be deployed through each opening 10. Each opening 10 may begenerally longitudinally-oriented, and generally rectangular in shape.Alternately, the orientation and/or shape of at least one opening 10 maybe different. The openings 10 may be organized into one or moregenerally-longitudinally-oriented rows, corresponding to the locationsof staples in the cartridge 2. As another example, the openings 10 maybe interconnected to form one or more larger openings, such that morethan one staple may be deployed through a single opening 10.Alternately, the upper surface 8 may be omitted altogether, therebyrendering openings 10 superfluous.

Referring also to FIGS. 2-4, the cartridge 2 also may include one ormore rails 12. The rails 12 may be oriented generally longitudinally,and may be shaped generally as rectangular solids. At least one rail 12may be dimensioned greater in lateral width than in vertical height, asseen most clearly in FIG. 3. As another example, at least one rail 12may be oriented and/or shaped in any other suitable manner. The rails 12may be spaced laterally apart from one another. The rails 12 may befabricated from any suitable material, and in any suitable manner. Atleast one rail 12 may be vertically spaced apart from the upper surface8 of the cartridge 2 by a gap 14. One or more pins 17 may extend from atleast one rail 12 across the gap 14 to the upper surface 8. The pins 17may be fabricated integrally with the corresponding rail 12 and/or uppersurface 8, or may be fabricated separately and later connected thereto.At least one pin 17 may be generally cylindrical in shape. However, atleast one pin 17 may be shaped differently. The pins 17 advantageouslyare shaped the same as one another, but at least one pin 17 may beshaped differently than at least one other pin 17.

A plurality of staples 16 may be affixed to and frangibly separable fromthe cartridge 2. The staples 16 may be shaped substantially in the samemanner as the staples described in the Feeder Belt Document, or may beshaped in any other suitable manner. Each staple 16 may have a free end18, and an opposite end 20 that is connected to a stem 22. The portionof the staple 16 between the free end 18 and the opposite end 20 may bereferred to as the tine 24. The stem 22 of at least one staple 16 may besubstantially perpendicular to the tine 24 of that staple 16. As anotherexample, the stem 22 and tine 24 of a staple 16 may be oriented at adifferent angle to one another. The stem 22 may be substantially planarand rectangular, but may be shaped differently if desired. Each tine 24may be fixed to the corresponding stem 22. Advantageously, the tine 24and corresponding stem 22 are integral, and may be fabricated bystamping a piece of flat sheet metal, then bending the tine 24 and thestem 22 to the desired angle relative to one another. Advantageously,each staple 16 is positioned on a corresponding rail 12, such that thestem 22 is positioned on top of that rail 12. The thickness of the stem22 may be substantially the same as the height of the gap 14 betweeneach rail 12 and the upper surface 8. Alternately, the thickness of atleast one stem 22 may be less than the height of the gap 14 between eachrail 12 and the upper surface 8. Each staple 16 may be fixed to theupper surface 8 of the cartridge and/or to a rail 12, in any suitablemanner. As one example, at least one stem 22 may include at least oneaperture 26 defined therethrough. That aperture 26 may receive acorresponding pin 17 that extends from the upper surface 8 to a rail 12.As another example, at least one stem 22 may be welded to the top of acorresponding rail 12 and/or to the bottom of the upper surface 8. Asanother example, at least one stem may be affixed to the top of acorresponding rail 12 and/or to the bottom of the upper surface 8 byadhesive. As another example, at least one stem 22 may be pressure-fitbetween the upper surface 8 and the corresponding rail 12. As anotherexample, at least one stem 22 may be fixed to a corresponding rail 12and/or the upper surface 8 in two or more ways, such as, for example, bywelding and by receiving a pin 17 through an aperture 26 in the stem 22.At least one staple 16 may be fabricated separately from a remainder ofthe cartridge 2, then affixed to the cartridge 2 as set forth above.Alternately, at least one staple 16 may be integral with a remainder ofthe cartridge 2.

The staples 16 may be arranged in the cartridge 2 in any suitablemanner. As one example, one or more staples 16 may be arranged against acorresponding rail 12, with each stem 22 fixed to the corresponding rail12. The staples 16 may be arranged relative to the rail 12 and to oneanother such that the tine 24 extending from a particular staple 16 ispositioned on one lateral side of the rail 12, and the tine 24 extendingfrom each longitudinally-adjacent staple 16 is positioned on the otherlateral side of the rail 12. In this way, the tines 24 alternate sidesrelative to the rail 12 longitudinally along the rail 12, as seen mostclearly in FIGS. 2-3. As another example, each staple 16 may include asingle stem 22, with two tines 24 extending from it. Each tine 24 mayextend from a lateral side opposed to the other. The stem 22 may bepositioned on top of a rail 12, with each stem 22 fixed to thecorresponding rail 12, and with each tine 24 positioned on a differentlateral side of the corresponding rail 12. One tine 24 may be positionedlongitudinally distal to the other tine 24 extending from the same stem22. Such staples 16 may be arranged relative to the rail 12 such thatthe tines 24 alternate sides relative to the rail 12 longitudinallyalong the rail 12. As another example, at least one staple 16 isintegral with the upper surface 8, and is affixed to a remainder of theupper surface 8 at the end 20 of the tine 24. In such a configuration,the staple 16 may be fabricated by punching, stamping, or otherwisedislodging it from the upper surface 8, such that the staple 16 extendsfrom one end of a corresponding opening 10 in the upper surface 8, andthe opening 10 results from the fabrication of the staple 16 associatedwith it. Further, in such a configuration, the stem 22 may be omittedfrom the staple 16. Regardless of the particular configuration of thestaples 16, each tine 24 may be positioned adjacent to a correspondingopening 10 in the upper surface 8, and/or may be affixed to the uppersurface 8 in proximity to the corresponding opening 10.

At least part of each staple 16 may be frangibly affixed to a remainderof the cartridge 2. “Frangibly affixed” is defined to mean that at leastpart of each staple 16 is fixed to a remainder of the cartridge 2 insuch a manner that it must be sheared or otherwise broken off from aremainder of the cartridge 2 to be removed therefrom. As one example, atleast one staple 16 may be frangible at the junction between the stem 22and the tine 24. Such a junction may have a weakened area to facilitatefrangibility. As another example, at least one staple 16 may remainintact during deployment, and the stem 22 of the staple 16 is frangiblefrom the corresponding rail 12 and/or the upper surface 8. As anotherexample, where the tine 24 is integral with the upper surface 8, thetine 24 may be frangible at the junction between the tine 24 and theupper surface 8.

The cartridge 2 may be actuated, and the staples 16 deployed,substantially as set forth in the Feeder Belt Document, with thefollowing general differences. The wedge assembly 4 includes one or morewedges 30 configured generally as set forth in the Feeder Belt Document.Initially, the wedge or wedges 30 may be positioned proximal to thecartridge 2. In this way, the wedge or wedges 30 do not interfere withthe insertion of the cartridge 2 into a remainder of the surgicalstapler. The cartridge 2 may be inserted into the stapler, or mayalready be present in the stapler, prior to actuation of the stapler.The wedge assembly 4 is moved distally, advantageously by sliding. Asthe wedge assembly 4 moves distally, it slides the wedge or wedges 30distally as well. Advantageously, one wedge 30 slides along acorresponding row of staples 16 to sequentially deform staples 16outward through the corresponding openings 10 in the upper surface 8,and then break staples 16 from the cartridge 2. Such deformation andlater breakage of the staple may be as set forth generally in the FeederBelt Document. As one example, the stem 22 of one or more staples 16 isheld substantially in place by its affixation to a corresponding rail 12and/or to the upper surface 8, as set forth above. As a wedge 30 slidesdistally relative to the staple 16, the wedge 30 first engages the tine24 of that staple 16, causing the tine 24 to move upward and to rotateabout the junction between the tine 24 and the stem 22. Rotation of thetine 24 upward causes the tine 24 to move up through a correspondingopening 10 in the upper surface 8, through tissue, and then move intocontact with an anvil (not shown), such as set forth in the Feeder BeltDocument. Contact between the tine 24 and the anvil deforms the tine 24to its closed configuration. As the wedge 30 continues to move distallyrelative to the staple 16, both the wedge 30 and the tine 24 may beshaped such that the wedge 30 may continue to contact and exert force onthe tine 24 after the tine 24 has been deformed. This force increasesuntil the tine 24 is broken, sheared or otherwise separated from thestem 22. As another example, this force increases until the stem 22 isbroken, sheared or otherwise separated from a remainder of the cartridge2, such as from a corresponding rail 12 and/or the upper surface 8 ofthe cartridge 2. The wedge 30 thereby may sequentially separate thefrangible staples 16 from a remainder of the cartridge 2.

A knife 6 also may be connected to the wedge assembly 4, and may slideupward through the corresponding knife slot 32 in the upper surface 8 asthe wedge assembly 4 moves distally through the cartridge 2. The knife 6may be actuated, and may cut tissue, substantially as set forth in theFeeder Belt Document. Optionally, the knife 6 may be omitted from thewedge assembly 4, if desired. The knife 6 may be configured to move intothe cartridge 2, then move upward through and out of the knife slot 32,then slide along the knife slot 32, then move downward through the knifeslot 32. In this way, the knife 6 may be held in a position in which itdoes not extend through the knife slot 32 both before and after it hascut tissue, in order to enhance safety for the user and the patient.

After the wedge assembly 4 has been actuated to deploy one or more ofthe staples 16, the cartridge 2 is spent. The wedge assembly 4 then maybe retracted proximally through and then out of the proximal end of thecartridge 2. The spent cartridge 2 then may be removed from a remainderof the surgical stapler. If desired, a new cartridge 2 may then beinserted into the surgical stapler in place of the previous, spentcartridge 2. The new cartridge 2 may be actuated substantially asdescribed above.

While the invention has been described in detail, it will be apparent toone skilled in the art that various changes and modifications can bemade and equivalents employed, without departing from the presentinvention. It is to be understood that the invention is not limited tothe details of construction, the arrangements of components, and/or themethod set forth in the above description or illustrated in thedrawings. Statements in the abstract of this document, and any summarystatements in this document, are merely exemplary; they are not, andcannot be interpreted as, limiting the scope of the claims. Further, thefigures are merely exemplary and not limiting. Topical headings andsubheadings are for the convenience of the reader only. They should notand cannot be construed to have any substantive significance, meaning orinterpretation, and should not and cannot be deemed to indicate that allof the information relating to any particular topic is to be found underor limited to any particular heading or subheading. Therefore, theinvention is not to be restricted or limited except in accordance withthe following claims and their legal equivalents.

What is claimed is:
 1. A method for surgical stapling, the methodcomprising: providing a cartridge and a plurality of surgical staplesaffixed to and frangibly separable from said cartridge, the plurality ofsurgical staples arranged in a row along a rail of the cartridge,wherein a stem of a staple of the plurality of surgical staples is fixedto the rail by a pin received through an aperture of the stem, the pinextending across a gap to one of the rail or an upper surface of thecartridge; providing at least one wedge; and moving said at least onewedge into said cartridge, the moving being collinear with the row,wherein said moving deforms and then shears from said cartridge at leastone of said plurality of surgical staples.
 2. The method of claim 1,further comprising: providing a surgical stapler; inserting saidcartridge into said stapler before said moving; and removing saidcartridge from said surgical stapler after said moving.
 3. The method ofclaim 1, wherein the at least one wedge has an inclined surface thatmoves collinearly along the row.
 4. The method of claim 1, wherein theplurality of surgical staples are affixed to an outer surface of alongitudinal rail extending within the cartridge.
 5. A method forsurgical stapling, comprising: providing a cartridge having a pluralityof surgical staples affixed to and frangibly separable from a surface ofa longitudinal rail of the cartridge, the plurality of surgical staplesarranged in a row along the surface, wherein a stem of a staple of theplurality of surgical staples is fixed to the rail by a pin receivedthrough an aperture of the stem, the pin extending across a gap to oneof the rail or an upper surface of the cartridge; and moving a wedgeinto the cartridge, the moving being collinear with the row, whereinsaid moving deforms and then shears from said cartridge at least one ofsaid plurality of surgical staples.
 6. The method of claim 5, whereineach surgical staple of the plurality of surgical staples has a firstend and a second end, the first end affixed to the stem, the stemaffixed to a top surface of the rail, and wherein the second end isbelow a plane defined by the first end of each of the plurality ofsurgical staples.
 7. The method of claim 5, wherein the cartridgeincludes a plurality of longitudinal rails and a plurality of wedges. 8.The method of claim 6, wherein the stem is affixed to the pin extendingfrom the top surface of the rail.
 9. The method of claim 7, wherein onewedge is dedicated to one of the plurality of longitudinal rails. 10.The method of claim 5, wherein the wedge has an inclined surface andwherein a surface of the staple slides along the inclined surface duringthe moving.
 11. The method of claim 10, wherein the inclined surfacecontacts multiple surgical staples contemporaneously.